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FDA 510(k)

INFANT PHOTOTHERAPY MASK

K-Number: K813214 · 1981-12-09

ApplicantMontrose Phototherapy Supply
Decision Date1981-12-09
Product CodeFOK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFANT PHOTOTHERAPY MASK is the device name listed in this FDA 510(k) record. The listed applicant is Montrose Phototherapy Supply. It received FDA 510(k) clearance on 1981-12-09 under 510(k) number K813214. The device is classified under product code FOK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFANT PHOTOTHERAPY MASK?

INFANT PHOTOTHERAPY MASK is a medical device that received FDA 510(k) clearance on 1981-12-09. The listed applicant is Montrose Phototherapy Supply. The 510(k) number is K813214.

When did INFANT PHOTOTHERAPY MASK receive FDA 510(k) clearance?

INFANT PHOTOTHERAPY MASK received FDA 510(k) clearance on 1981-12-09, under 510(k) number K813214.

Who is the listed applicant for INFANT PHOTOTHERAPY MASK?

The FDA 510(k) record lists Montrose Phototherapy Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFANT PHOTOTHERAPY MASK?

The FDA product code for INFANT PHOTOTHERAPY MASK is FOK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Montrose Phototherapy Supply as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K813188INFANT PHOTOTHERAPY LIGHT

Related Devices (Code: FOK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962290DEROYAL INDUSTRIES, INC. NEONATAL EYE COVERDebusk Technology Corp.K926118LIFE TRACE(R) BILIRUBIN MASKGraphic Controls Corp.K851918INFANT PHOTOTHERAPY MASKAlba Health CareK840894PHOTO-THERAPY EYE PROTECTORA & A Medical Supplies Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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